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Safety/Tolerability, Pharmacokinetics/Pharmacodynamics (PK/PD) of LCZ696 in Patients With Stable Heart Failure

NCT ID: NCT00913653

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Brief Summary

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This study assess the safety/tolerability, PK/PD of LCZ696 in patients with stable heart failure.

Detailed Description

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Conditions

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Heart Failure

Keywords

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Heart failure LCZ696

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stable heart failure patients

Group Type EXPERIMENTAL

LCZ696

Intervention Type DRUG

Interventions

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LCZ696

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with documented heart failure (NYHA class II-IV)

Exclusion Criteria

* Use of both ACEi and ARB, ACEi and DRI, ARB and DRI treatment, or all three medications at Screening
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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GOUVPO Russian Peoples´ Friendship University, Center of Applied

Moscow, , Russia

Site Status

Countries

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Russia

References

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Kobalava Z, Kotovskaya Y, Averkov O, Pavlikova E, Moiseev V, Albrecht D, Chandra P, Ayalasomayajula S, Prescott MF, Pal P, Langenickel TH, Jordaan P, Rajman I. Pharmacodynamic and Pharmacokinetic Profiles of Sacubitril/Valsartan (LCZ696) in Patients with Heart Failure and Reduced Ejection Fraction. Cardiovasc Ther. 2016 Aug;34(4):191-8. doi: 10.1111/1755-5922.12183.

Reference Type RESULT
PMID: 26990595 (View on PubMed)

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=3202

Results for CLCZ696A2117 from the Novartis Clinical Trials Website

Other Identifiers

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CLCZ696A2117

Identifier Type: -

Identifier Source: org_study_id